Video-Guided Jaw Relaxation and Breathing Exercises in Children With Burns

NCT07796243 | Not Yet Recruiting

• 1 other identifier: 27826
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to evaluate the effects of video-guided jaw relaxation and video-guided breathing exercises on anxiety, fear, and dressing duration in children with burns. Children aged 4-10 years receiving inpatient care in a pediatric burn unit will be randomly assigned to one of three groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Children in the intervention groups will perform the assigned exercise simultaneously with a 5-minute video before burn dressing, while children in the control group will receive routine care. Anxiety and fear will be assessed at three time points: before the intervention (T1), immediately after the intervention and before dressing (T2), and immediately after dressing (T3). Dressing duration will also be recorded. The study will determine whether these brief, video-guided non-pharmacological interventions reduce anxiety and fear associated with burn dressing and affect dressing duration in children.

Conditions

Burn

Keywords

anxiety; fear; wound dressing

Outcome Measures

Primary Outcomes (2)

• Anxiety Level

  Anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S). The CAM-S is a visual scale designed to assess children's current state anxiety. Higher scores indicate higher levels of anxiety.

  At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).

• Fear Level

  Fear will be assessed using the Child Fear Scale (CFS), which consists of five facial expressions ranging from 0 (no fear) to 4 (severe fear). Higher scores indicate higher levels of fear.

  At three time points: 15 minutes before dressing (T1), immediately before dressing following the 5-minute intervention (T2), and immediately after dressing (T3).

Secondary Outcomes (1)

• Wound Dressing Duration

  During the burn dressing procedure

Study Arms (3)

Control Group

NO INTERVENTION

Children assigned to the control group will receive routine care without any video-guided relaxation or breathing intervention. Anxiety and fear will be assessed at the same time points as in the intervention groups: before the dressing procedure (T1), immediately before dressing (T2), and immediately after completion of the dressing procedure (T3). The total duration of the dressing procedure will also be recorded.

Video-Guided Breathing Exercise Group

ACTIVE COMPARATOR

Intervention Description: Children assigned to this group will receive a 5-minute video-guided breathing exercise before burn dressing. The video will demonstrate a slow inhale-exhale-rest breathing rhythm, and children will be instructed to perform the breathing exercise simultaneously while watching the video. The video will not include any instructions regarding

Behavioral: Video-Guided Breathing Exercise

Video-Guided Jaw Relaxation Group

ACTIVE COMPARATOR

Children assigned to this group will receive a 5-minute video-guided jaw relaxation intervention before burn dressing. The video will demonstrate allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and following a slow inhale-exhale-rest breathing rhythm. Children will be instructed to perform the demonstrated exercises simultaneously while watching the video. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.

Behavioral: Video-Guided Jaw Relaxation

Interventions

Video-Guided Jaw Relaxation BEHAVIORAL

1\. Video-Guided Jaw Relaxation Intervention Description: Children assigned to this group will receive a 5-minute video-guided jaw relaxation intervention before burn dressing. The video will demonstrate allowing the lower jaw to drop slightly, keeping the tongue relaxed on the floor of the mouth, relaxing the lips, and following a slow inhale-exhale-rest breathing rhythm. Children will be instructed to perform the demonstrated exercises simultaneously while watching the video. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.

Video-Guided Jaw Relaxation Group

Video-Guided Breathing Exercise BEHAVIORAL

Children assigned to this group will receive a 5-minute video-guided breathing exercise before burn dressing. The video will demonstrate a slow inhale-exhale-rest breathing rhythm, and children will be instructed to perform the breathing exercise simultaneously while watching the video. The video will not include any instructions regarding relaxation of the jaw, tongue, or lips. Immediately after the 5-minute intervention, anxiety and fear will be assessed before the dressing procedure.

Video-Guided Breathing Exercise Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-10 years
• Receiving inpatient treatment in the Pediatric Burn Unit
• Having undergone at least three previous burn dressing procedures
• Able to communicate in Turkish
• No visual or hearing impairment that would prevent participation in the video-guided intervention
• No administration of an anxiolytic medication before the dressing procedure that could affect the study outcomes
• No burns involving the face or neck
• Child and parent/legal guardian willing to participate in the study and provide the required assent/consent

You may not qualify if:

• Child or parent/legal guardian requesting withdrawal from the study
• Inability to tolerate or complete the assigned video-guided jaw relaxation or breathing exercise
• Development of a serious clinical complication or requirement for intensive care during data collection
• Inability or refusal to comply with the study protocol, including discontinuation or refusal of the assigned intervention

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

MeSH Terms

Conditions

Burns; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders

Study Officials

• Esra Ardahan Akgül, PhD

  İzmir Katip Çelebi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to group allocation. Randomization and delivery of the interventions will be performed by a separate researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: Participants will be randomly assigned to one of three parallel groups: video-guided jaw relaxation, video-guided breathing exercise, or control. Each participant will remain in the assigned group throughout the study, with no crossover between interventions.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09